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A method for detecting related substances in edaravone sodium chloride injection

A technology of edaravone sodium chloride and a detection method, which is applied in the field of drug analysis, can solve problems such as affecting drug efficacy and activity, imperfect chromatographic conditions, and increasing adverse drug reactions, and achieves accurate quality control methods, high sensitivity, and variety many effects

Active Publication Date: 2020-10-02
JIANGSU CHIA TAI FENGHAI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Studies have found that Edaravone in a solid state is relatively stable, but its aqueous solution is prone to oxidation-reduction reactions and degradation. The amount of impurities affects the efficacy and activity of the drug on the one hand, and may increase the adverse reactions of the drug on the other hand; therefore Edaravone The inspection method of impurities in sodium chloride injection is of great significance to control its clinical efficacy
[0006] However, the existing domestic and foreign literature on related substances of Edaravone or its preparations is mainly controlled by HPLC method, but the chromatographic conditions for determining related substances in domestic quality standards are not perfect, and the related substances of this product cannot be effectively detected. It is difficult to evaluate the quality of Edaravone, especially Edaravone Sodium Chloride Injection

Method used

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  • A method for detecting related substances in edaravone sodium chloride injection
  • A method for detecting related substances in edaravone sodium chloride injection
  • A method for detecting related substances in edaravone sodium chloride injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Example 1 Determination of Impurities in Edaravone Sodium Chloride Injection by High Performance Liquid Chromatography

[0037] Determine according to high-performance liquid chromatography (Chinese Pharmacopoeia 2015 edition four general rules 0512).

[0038] Chromatographic conditions and system suitability test: using octadecylsilane bonded silica gel as filler (Kromasil C 18 , 250 × 4.6mm, 5 μ m); With 0.4% triethylamine acetate aqueous solution as mobile phase A, with methanol as mobile phase B, carry out gradient elution as shown in the table below; the flow rate is 1.0ml per minute, and the detection wavelength is 244nm; The temperature is 30°C. The separation between the main peak and its adjacent peaks should meet the requirements.

[0039]

[0040] Assay method: take an appropriate amount of this product as the test solution (the test solution needs to be measured within 4 hours); accurately measure 1ml, put it in a 100ml measuring bottle, add water to di...

Embodiment 2

[0043] Example 2 Determination of Impurities in Edaravone Sodium Chloride Injection by High Performance Liquid Chromatography

[0044] Determine according to high-performance liquid chromatography (Chinese Pharmacopoeia 2015 edition four general rules 0512).

[0045] Chromatographic conditions and system suitability test: using octadecylsilane bonded silica gel as filler (Aglinet C 18 , 150 × 4.6mm, 5 μm is applicable); With 0.3% triethylamine acetate aqueous solution as mobile phase A, with methanol as mobile phase B, carry out gradient elution as shown in the table below; flow rate is 0.9ml per minute, and detection wavelength is 244nm; The column temperature was 40°C. The separation between the main peak and its adjacent peaks should meet the requirements.

[0046]

[0047]

[0048]Assay method: take an appropriate amount of this product as the test solution (the test solution needs to be measured within 4 hours); accurately measure 1ml, put it in a 100ml measuring ...

Embodiment 3

[0051] Example 3 Determination of Impurities in Edaravone Sodium Chloride Injection by High Performance Liquid Chromatography

[0052] Determine according to high-performance liquid chromatography (Chinese Pharmacopoeia 2015 edition four general rules 0512).

[0053] Chromatographic conditions and system suitability test: using octadecylsilane bonded silica gel as filler (YMC C 18 , 150×4.6mm, 3.5μm applicable); 0.2% triethylamine acetate aqueous solution is used as mobile phase A, methanol is used as mobile phase B, and the gradient elution is carried out in the following table; the flow rate is 0.8ml per minute, and the detection wavelength is 244nm ; The column temperature is 35°C. The separation between the main peak and its adjacent peaks should meet the requirements.

[0054]

[0055] Assay method: take an appropriate amount of this product as the test solution (the test solution needs to be measured within 4 hours); accurately measure 1ml, put it in a 100ml measuri...

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Abstract

The invention mainly provides a method for detecting related substances in an edaravone sodium chloride injection through a high-performance liquid chromatography. The method provided by the inventiontakes octadecyl silane bonded silica gel or octyl silane bonded silica gel as a filling agent and 0.2 percent to 0.4 percent of glacial acetic acid triethylamine-methanol as a mobile phase; the detection wavelength is 240 to 260nm, the column temperature is 20 to 40 DEG C and the flow speed is 0.5 to 1.0ml / min; gradient elution is carried out and edaravone and the related substances in the edaravone sodium chloride injection can be simultaneously detected. The method is simple to operate and high in sensitivity and the quality of products can be controlled relatively well.

Description

technical field [0001] The invention belongs to the field of drug analysis, in particular to a method for detecting related substances in Edaravone sodium chloride injection, a powerful free radical scavenger. Background technique [0002] Edaravone (Edaravone, 3-methyl-1-phenyl-2-pyrazolin-5-one) is a pyrazolone compound synthesized from phenylhydrazine and ethyl acetoacetate, which has a powerful free radical Scavenging effect, its molecular weight is C 10 h 10 N 2 O, the molecular weight is 174.20, and the structural formula is: [0003] [0004] Edaravone is a central nervous system drug developed by Mitsubishi Tokyo Pharmaceutical Co., Ltd., which was first launched in Japan in 2001. It can effectively reduce the neurological symptoms and dysfunction caused by brain tissue damage after cerebral infarction. It is mainly used clinically to treat acute infarction. Hemorrhagic stroke. As the first new oxygen free radical scavenger, it has the functions of scavenging...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/34
CPCG01N30/02G01N30/34
Inventor 马利华赵悦叶海英杜柳辉
Owner JIANGSU CHIA TAI FENGHAI PHARMA
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